Marketing

Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children

By Mark A. York (August 3, 2018)

Employers spent $2.6 billion on opioid addiction in 2016

$1.5 billion+ was spent on children with opiate addiction issues

(MASS TORT NEXUS MEDIA) The now commonly known costs associated with employers treating opioid addiction and the affiliated issues have increased eight hundred percent since 2004 to an eye-watering $2.6 billion in 2016, a new report reveals.

The latest analysis shows that half of the cost was spent covering employees’ children.

A recent Kaiser Family Foundation report found that prescription use of addictive painkillers among people with employer offered health coverage is now at the lowest levels in 10 years.

This comes shortly after a CDC study revealed there was been a nearly 30 percent increase in overdoses between 2015 and 2016.

According to the Centers for Disease Control and Prevention, opioids killed more than 42,000 people in 2016, more than any year on record.

With 40 percent of those deaths involving a prescription opioid such as Oxycontin and Vicodin and other widely prescribed opiates. This has also resulted in the multi-billion lawsuits filed against Opioid Big Pharma drug makers and distributors by cities, counties and states across the country, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”with the drug makers and distributors scrambling to defend the opiate marketing strategies that have caused billions and billions of dollars in costs, medical damages and loss of productivity annually in the United States.

The Kaiser Family Foundation found that the $2.6 billion spending cost companies and workers about $26 per enrollee in 2016, which now appears to be a “man-made” healthcare cost increase associated with the widely accepted Opiate Big Pharma marketing practices over the last 20 years. This include telling doctors and the healthcare industry that “opiates are not as addictive as they used to be” and “we’ve altered the drug compound to control opiate release” which was the widely used Purdue Pharma marketing strategy.

Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report found that spending on opioid prescriptions falling 27 percent from a peak in 2009 – when 17.3 percent of large employer plan enrollees had at least one opioid prescription during that year. However, by 2016, that number dropped to 13.6 percent.

These drugs relieve pain by attaching to specific proteins called opioid receptors, which are found on nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs in the body. When they attach to these receptors, they reduce the perception of pain.

[STUDY OBJECTIVES:The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Prescription opioids and illicit drugs have become incredibly pervasive throughout the US, and things are only getting worse.

In the early 2000s, the FDA and CDC started to notice a steady increase in cases of opioid addiction and overdose. In 2013, they issued guidelines to curb addiction.

However, that same year – now regarded as the year the epidemic took hold – a CDC report revealed an unprecedented surge in rates of opioid addiction.

Overdose deaths are now the leading cause of death among young Americans – killing more in a year than were ever killed annually by HIV, gun violence or car crashes.

Preliminary CDC data published by the New York Times shows US drug overdose deaths surged 19 percent to at least 59,000 in 2016.

That is up from 52,404 in 2015, and double the death rate a decade ago.

It means that for the first time drug overdoses are the leading cause of death for Americans under 50 years old.

The data lays bare the bleak state of America’s opioid addiction crisis fueled by deadly manufactured drugs like fentanyl.

These drugs also effect the brain regions involved in reward, so it can also produce a sense of pleasure by triggering the same processes that make people feel good when they are having fun or sex.

Experts say many people’s first contact with opioids is through some form of social contact: either a friend who was sent home with Oxycontin after a surgical procedure or a relative who received an opioid prescription for chronic pain.

‘Opioids, are not a bacteria virus, but the drug, in this case, spreads through social networks…even in some ways a virus, like HIV, is spread to a great degree through social networks,’ he added.

Due to the link between hospitals and the opioid crisis, doctors have been coming up with innovative ways to curb the epidemic.

However, hospitals have been doing their part in trying to curb the opioid epidemic.

For instance, the ER department at St. Joseph University Medical Center in New Jersey managed to halve the rate of opioid prescriptions by using dry needles and laughing gas to treat chronic pain.

In 2016, the department launched an Alternative to Opiates program that uses trigger point injections and a local anesthetics in lieu of opioids to relieve pain. Other alternative pain relieving methods they used was warm compressors and music – they have a harpist roam the halls playing tunes to soothe the patients.

Dr Mark Rosenberg, chair of emergency medicine, said he and his colleagues founded the program after they realized chronic pain was one of the reasons most patients came to their emergency department.

‘We wanted to develop an aggressive acute pain management program that focused on evidence based principles but avoided opioids,’ Dr Rosenberg said.

St. Joseph University Medical Center isn’t the only hospital to implement this program, Kaiser Permanente has implemented an Integrated Pain Service, an eight-week course designed to educate high-risk opioid patients about pain management.

Some experts have stated that the beginning of the end of the epidemic may be near due to tightened regulations on opioid prescription monitoring, local-level efforts to make naloxone, an anti-overdose drug, and drug-assisted rehabilitation more accessible to high-risk populations. Then there are many more “experts” who state that the opioid crisis and the future affiliated issues are going to be on the healthcare, insurance and socio-economic forefront of America for at least the next generation.

Broken Families, Less Funding

The patterns of parent addiction that overflows into child addiction is something that wasn’t part of the opiate equation until fairly recently, where employer issues now mirror a national trend of multiple generations being addicted to opiates. Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions

Local efforts are now seen as the primary way to address the opioid crisis in children- the attempt to secure federal intervention and support to help curb the opioid crisis has not been a priority of the Trump Administration..

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses. The FDA will receive comments on this proposal through February 5, 2018.

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States. The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

Opioid Industry Model of “Profits Before Patients” and The Impact on American Children

By Mark A. York (July 5, 2018)

(MASS TORT NEXUS MEDIA) In West Virginia, home of the highest overdose rates in the nation, the foster population has increased by 42 percent since 2014.

The number of children in state or foster care hit a record low in Massachusetts earlier this decade. Since then, that number has risen by a quarter, and there are now more children in state care than ever before.

In Ohio, the number of children in state custody has grown by 28 percent since 2015. Foster populations are up more than 30 percent in Alabama, Alaska, California, Idaho, Indiana, Minnesota and New Hampshire since 2014. states like Illinois, Oklahoma, Massachusetts, Pennsylvania, Colorado and New Jersey now adopting new approaches to help keep parents and children together, even as parents are receiving treatment for their addictions.

The opioid epidemic plaguing the nation is taking a catastrophic toll on our most vulnerable group, the children of the opiate addicts and those with substance use disorders. Many children are sent to live with grandparents or other family members, often due to a parent overdose or other addiction displays other problems but tragically, a growing number are being placed in the foster-care system, with many states unable to keep up with the demand from both a budget as well as staffing is struggling to keep up with demand.

From 2013 to 2015, the number of children in foster care nationwide jumped almost 7 percent to nearly 429,000, according to the U.S. Department of Health and Human Services’ Administration on Children and Families, the 2016 to 2018 numbers have moved that number closer to 550,000. Parental substance use was cited as a factor in about 32 percent of all foster placements. From 2000 to 2015, more than half a million people died of an overdose, and currently 91 people a day die from opiate overdoses.

Unfortunately, many children, the indirect victims of the crisis, are not getting the care and services they need. “This is a neglected subpopulation,” says John Kelly, PhD, associate professor of psychiatry in addiction medicine at Harvard Medical School, and the founder and director of the at Massachusetts General Hospital. “Because we’re trying to put out the fire in terms of stopping overdose deaths, we haven’t really been attending to other casualties, including kids most importantly.”

To lessen the long-term effects on children, psychologists are treating children in the foster-care system in outpatient, inpatient and residential treatment programs and in school-based mental health programs.

[STUDY OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Everett Washington Schools and Opioids

The front office at an elementary school was never intended as an intake center for drug-counseling and social-services referral hub. For 31 year old Tiffany Smith and others in Everett, it has become just that for the last two years, as she attempts to end her heroin addiction while raising three children.

Smith often chats with the office staff and updates Principal Celia O’Connor-Weaver on her progress in treatment. The first time she ventured inside, Smith carried paperwork from Child Protective Services, and needed to tell the principal that her children, who taken into foster care months before might still get visits from state social workers, even now that the kids were returned home.

Explaining all of this to the principal meant describing what led to the boys’ removal, which meant confessing that she had been addicted to opiates, at times living in her car, the kids staying at her grandmother’s house, until her grandmother finally called state authorities.

“I was afraid of the judgment, that my kids would be affected at school , but it wasn’t that way at all. They said they have a lot of parents that have gone through opiate addictions and what can we do to help? It was not what I was expecting.”

In her six years as principal at the elementary school in Everett, an epicenter of the opioid crisis in Washington, 525 Snohomish County kids were removed from addicted parents just in 2017, in Seattle’s King County, more than 1,000 children were removed.

This problem is now prevalent across the United States where schools, social service agencies and public-health workers scramble to stem adult addictions, less visible have been the reverberations downstream, the children of opioid addicts. Educators and child-welfare workers have reported increased learning problems and behavioral outbursts from the kids of addicted parents. Research suggests dire life-outcomes for these students. Yet the potential for school-based interventions has been underutilized — even as public-health investigators say schools offer the most efficient hope for stemming a looming social crisis.

During the most mundane moments, like recess, teachers watch and 8-year-olds pretend to revive overdosed patients, or hearing how a parent confesses that they’ve relapsed.

The focus of schools should be learning and teaching kids, but often many kids’ minds are not focused on that, they’re worried about their parents, about their next meal and who’s going to be home to take care of them. When a parent becomes addicted or goes into rehab, it changes everything for a family.

Drug users’ children flooding to foster care

In Tiffany Smith’s case, three years of methadone treatment have helped her regain solid enough footing to secure housing and begin working toward a GED, in hopes of becoming a drug and alcohol counselor. But her children are still reeling. Smith’s 6-year-old cannot stand to be apart from his mother and struggles with speech, cognitive and learning delays.

“He was talking fine before foster care,” Smith said. “But when he came out, he couldn’t pronounce some words. They said it was due to the trauma.”

Her older son, now 7, was born prematurely and spent his first two days of life trembling from heroin withdrawal as his mother watched, devastated. “Seeing my baby shake from detoxing really hurt — I knew it was my fault,” she said.

In Washington state, this number is alarming, but not widely known, 10,000 high-school seniors said they’d used heroin or gotten high on opioid-derived painkillers in 2016, those numbers were about the same as two years prior, but foster care placements have surged.

Between 2011 and 2017, the state took children from drug-abusing parents nearly 14,000 times. Last year’s rate was the highest for drug-related causes since 2010 — up 16 percent over 2015 — while state hospitals report a steady increase in substance-exposed newborns.

Child-welfare workers hear complaints about increasingly severe problems in school — more physical violence toward peers, or kids who need to be taught separately — from students whose parents are staggering through addiction, said Jenna Kiser, who oversees intake at the state Children’s Administration.

Jenny Heddin, a state agency supervisor stated, “These numbers are very concerning, when children from these homes come into foster care, they can be very difficult to serve.”

This represent one corner of a national wave. More than 37 states report unprecedented numbers of kids entering foster care, many of them for reasons related to a parent’s substance abuse, according to the federal Department of Education.

Damaging children’s futures

By the time Child Protective Services is knocking on someone’s door, the problem is already severe. And so far, efforts to respond might best be described as triage — focused more on addiction treatment than prevention, both in Washington and across the country.

As in many other states political infighting prevents treatment, earlier this year, Washington Gov. Jay Inslee proposed spending $20 million on a multipronged effort to combat opioid addiction. The bill never made it to the floor for a full vote, and it contained little funding for prevention. (But $1.7 million targeted for youth did get funding.)

Yet researchers warn that ignoring that aspect of the crisis virtually guarantees costly problems to come as the children of addicts grow into adulthood. Kevin Haggerty, a professor at the University of Washington who studies risk factors for drug abuse, authored one of the few peer-reviewed studies tracking life outcomes for these young people.

In the early 1990s, he identified 151 elementary and middle-school children in Washington who were growing up with heroin-addicted parents. Fifteen years later, as young adults, 33 percent had dropped out of high school. The vast majority were addicts themselves, and half had criminal records. Only 2 percent had made it through college. (Nationally, 33 percent of all kindergartners in 1992 grew up to earn a college degree.)

“The results are astounding at how poor the outcomes are, having a drug-addicted parent,” said Caleb Banta-Green, principal research scientist at the Alcohol and Drug Abuse Institute at the University of Washington’s School of Public Health.

“We need to be doing a lot more for kids being parented by opiate-addicted parents — and we’re not.”

“Families literally bring their problems to our door now to help them navigate their lives,” Harrington-Bacote said. “Public schools are doing things that fall way outside of regular academic education. But if they don’t, it’s not going to get addressed at all.”

OHIO EXAMPLES OF HOW BIG PHARMA OPIOID Rx MONEY DESTROYS LIVES

Way before social workers showed up in his living room this March, Matt McLaughlin, a 16-year-old with diabetes, had taken to a routine not of his doing, trying to scrounge up enough change for food while his mom, Kelly, went out to use heroin. On a good night, the high school junior would walk his neighborhood in Andover, Ohio to pick up frozen pizza from the dollar store, and on bad nights, he’d play video games to keep his mind off his hunger and unknown blood sugar levels.

When Matt was little, his mom Kelly was a Head Start caseworker who taught parents how to manage their autistic children, who hosted potlucks and played Barbie with Matt’s sister, Brianna. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”

Kelly had neck surgery and got addicted to OxyContin, and by 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, food became scarce, life changed for the worse, “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”

Ashtabula County Children Services a tip when someone called the police and urged them to check on the family.

She’d been to detox several times over the years, trying to rid herself of what felt like a demon that had taken over her brain. Last year, she managed to stay clean for 63 days, until a friend came over “and laid out a line—and that was all it took.” There are five heroin dealers within a five-mile radius and all more than willing to provide an addict the opiate of choice, which is the norm for rural Ohio anymore.

He kids were once again forced to pack their bags as Kelly would go to detox another time, they were lucky to have relatives nearby: The spiraling opioid epidemic has disrupted so many families that all the foster homes in Ashtabula County are full, this story is repeated across the country every day.

The scourge of addiction to painkillers, heroin, and fentanyl sweeping the country has produced a flood of bewildered children who, having lost their parents to drug use or overdose, are now living with foster families or relatives. In Ashtabula County, in Ohio’s northeast corner, the number of children in court custody quadrupled from 69 in 2014 to 279 last year. “I can’t remember the last time I removed a kid and it didn’t have to do with drugs,” says a child services supervisor. Her clients range from preschoolers who know to call 911 when a parent overdoses to steely teenagers who cook and clean while Mom and Dad spend all day in the bathroom. Often, the kids marvel at how quickly everything changed—how a loving mom could transform, as one teenager put it, into a “zombie.”

The pattern mirrors a national trend: Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.

More Broken Families, Less Funding

Ohio also has one of the nation’s highest overdose rates. In 2016, at least 4,149 Ohioans died of drug overdose—a 36 percent jump from the year before, according to the Columbus Dispatch. In 2015, 1 in 9 US heroin deaths occurred in Ohio.

It’s hard to overstate just how pervasive the epidemic feels here. Detective Taylor Cleveland, who investigates drug cases in Ashtabula, told me, “I’m dealing with ruined homes two and three times a day.” Cleveland, who coaches youth soccer and recently adopted a 17-year-old player whose mom overdosed, leads a task force that responds to every overdose in the county. Once, he arrived at an overdose scene only to realize that the victim slouched over in the motel room was his cousin, whose young daughter had called 911. “Every OD that happens, I get a text. I’ve gotten two texts while we’ve been talking.” We’d been talking for less than an hour.

Given the scale of the crisis, it’s not hard to understand why, when Donald Trump promised Ohioans on the campaign trail to “spend the money” to confront the opioid crisis and build a wall so drugs would stop flowing in, locals in this historically blue county took notice. In late October, Trump became the first presidential candidate since John F. Kennedy to visit Ashtabula County. He promised to bring back jobs, to open the long-shuttered steel plants, to build the wall. Twelve days later, Ashtabula residents voted for a Republican president for the first time since Ronald Reagan in 1984.

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

“I think some people felt as though nothing else is working,” said one Ashtabula resident when I asked why so many in a Medicaid-dependent area would vote for Trump. Now, she says, “I’m really, really scared. You don’t get it until you live in a small town and you see people die every day.”

Like so many other Midwest Rust Belt counties, Ashtabula, Ohio has seen better days. Locals proudly tell me that the Port of Ashtabula used to be one of the biggest in the world, where barges unloaded iron mined from Minnesota’s Mesabi Range onto trains headed for the steel mills of the Ohio River Valley. Today, once-bustling streets have given way to vacant storefronts and fast-food chains; the surrounding countryside is made up of farm fields, trailer parks, and junkyards. One in three kids now live below the federal poverty line, less than half of adults have a high school education. The financial downturn accelerated in the ’90s, when manufacturing jobs started disappearing.

Then Opiate Big Pharma and their marketing campaigns introduced newer “less addictive” painkillers like OxyContin and others like Vicodin were liberally prescribed in communities wrestling with dwindling economic opportunity and rife with workplace injuries common to mines, lumberyards, and factories. As authorities started to tighten the rules on prescribing drugs like OxyContin, the use of heroin, which is chemically nearly identical to opioid painkillers, crept up. But the tipping point, for Ohio and the country, came over the past couple of years, when illicit fentanyl, an opioid up to 100 times more powerful than morphine, started making its way into the heroin supply. Since then, says Dr. Thomas Gilson, the medical examiner for nearby Cuyahoga County, the deaths have been coming “like a tidal wave.”

About five years ago, Ohio noticed a major uptick in the number of parents using heroin. More recently, elected officials have learned more about the parasitic way that opioids co-opt the brain and the complex pull of addictions attitudes have softened, with most realizing, there is no good guy or bad guy, once addiction takes hold. The long term problems are often multiplied many times over by lack of short term treatment.

Gov. John Kasich, a notorious budget hawk, made national news when he pushed Medicaid expansion through Ohio’s conservative Legislature. “When you die and get to the meeting with St. Peter,” he told one lawmaker, “he’s probably not going to ask you much about what you did about keeping government small. But he is going to ask you what you did for the poor.” He made news yet again last week, when he signed a 2018 budget that will, for the first time in years, increase the state’s funding for children’s services. Yet the $30 million boost in funding over two years, which will pay foster parents and provide counseling for the kids, won’t make up for the $55 million increase in child placement costs over the past three years. Other than county pilot programs, “No policy or state investment has focused specifically on the children flooding into county agency custody as a result of the opioid epidemic,” concluded a report by the Public Children Services Association of Ohio this spring.

Meanwhile, federal funding for children’s services decreased by 16 percent between 2004 and 2014. That’s due in part to an arcane law stipulating that the largest pot of federal money for children’s services applies only to kids from below a certain income threshold. In many states, that threshold is about half the poverty level—in Ohio, it’s roughly $14,000 per year for a family of four. But the opioid epidemic has afflicted families of all stripes. “A few years ago, I was constantly just in homes that were clearly in poverty,” says Mongenel. Now she’s struck by her new clients’ well-kept houses: “You pull up to it and it’s like, ‘Really?’”

The director of one Ohio county stated “that more caseworkers are quitting than ever before, unable to reconcile the overwhelming caseload with the paltry salary, which starts at $28,500..’”

Another addiction case is Amber, a 16-year-old whose mother, Emily, was in and out of rehab for a year, while Emily cycled in and out of rehab. In December, officials got the phone call that Emily had been found dead, slumped over in a motel bed, and a social services worker had to break the news to Amber that they had run out of chances, her mother had died. Today, Amber lives in a what is her new home, a bustling house with nine other foster kids.

Then there is Jake, another 6-year-old with boy-band looks who lived for months in a motel over the 2017 winter with his two younger siblings, taking courses online and playing video games, while his mom went out to use. “He just wanted her to go into rehab and get right,” he told a reporter earlier this year, “If that could be my birthday present or my Christmas present, that’s what it would be.”

Lisa is a 10-year-old, introduced to Ohio social services for the first time in a conference room at her elementary school, the agency rep told her “We’re from children’s services have you ever heard of that before?” Lisa nodded and replied “they’re the people who go to her friend’s house once a month to make sure everything is okay,” in a matter of fact way.

Lisa was asked, “Do you have enough to eat?” and “Do you like where you’re staying?” and Do you know what drug use is?” but it wasn’t mentioned that CPS had just visited Lisa’s house and found her father strung out on heroin in the bedroom they share. Lisa’s bed was a pink sleeping bag on a piece of foam surrounded by pill bottles.

Children in Lisa’s situation are subject to incredible psychological stress. There’s the immediate trauma of living with an unstable parent or being taken from family and sometimes from school and friends. But there’s also the long-term impact. Dozens of studies have found that kids who undergo traumatic events early in life are more likely to suffer mental and physical repercussions later on, be it substance abuse, depression, heart disease, or cancer. Among the 10 so-called Adverse Childhood Experiences, or ACEs, are emotional abuse, physical abuse, separation from parents, and parental substance abuse.

“Every time a child gets into a scary or dangerous situation, it activates their stress response,” explains Dr. Nadine Burke Harris, a pediatrician and founder of the Center for Youth Wellness, which focuses on the developmental effects of childhood trauma. “The repeated activation of their stress response is what leads to the biological condition that we in pediatrics are now calling toxic stress.” Looking at the brains of kids of drug users, Burke Harris says, one would expect to see the signs associated with other types of trauma: an enlarged amygdala, the brain’s fear center; decreased functioning of the nucleus accumbens, the brain’s pleasure and rewards center; and less activity in the prefrontal cortex, which oversees a child’s ability to control impulses and pay attention.

CPS and affiliated social services agencies across the United States are now becoming much more familiar with the latest addiction research on ACEs and impacts on young children. They know that a child with four or more ACEs is twice as likely as other kids to develop cancer and ten times more likely to inject drugs themselves. When they encounter someone like Lisa, they are torn between mitigating one ACE, exposure to parental substance abuse, and catalyzing another: separating a child from her parents. Which is what makes these conversations so heart-wrenching.

For county and state professionals, one of the most difficult things about managing opioid cases is how unpredictable they can be, never knowing how a client’s drug-addicted parent will do after detox. Some thrive and are quickly reunited with their families. Others can’t pull themselves out of the black hole of addiction.

One positive outcome amid the many negatives, is the mother of Matt, the diabetic teenager, Kelly had sailed through detox and been sober for nearly a month, her daughter Brianna had moved back in to help her mom. In the fall Brianna is leaving for college—training to be a social worker, Kelly joked “I’m going to be her first case,” and added “When I was using, I would sleep half the day away” and wake up feeling sick from heroin cravings, she said. “Now I’ve been setting my alarm. I wake up early, enjoy my coffee, open the blinds, and let in the sunshine.” On her walks to town, she said, she crossed the street and looked straight ahead to avoid catching a glimpse of her dealer’s house, an ever-present temptation. Brianna and Matt often visit Kelly at an addiction treatment center.

Every 19 minutes, an opioid addicted baby is born in America., while many of us are well aware of the repercussions of addiction in adults, but very little is understood about the impact it has on infants. After months of being fed opioids through the mother, these babies suffer through excruciating pain.

Imagine, then, how it feels for a baby. Infants who have been exposed to opioid painkillers like morphine, codeine, oxycodone, methadone treatment or street drugs such as heroin while in utero are literally cut off from the drugs when they are born. Within their first 72 hours of life, about half of the babies who have been exposed begin having withdrawal symptoms.

The medical term for this is neonatal abstinence syndrome, or NAS, and rates of babies born with it are rising along with the exponential increase of painkiller use and abuse.

A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions.

Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

In Canada, in the past decade, the number of babies exposed to opioids in the womb has increased 16-fold in Ontario. And according to Ontario’s Provincial Council for Maternal and Child Health (PCMCH), more than 950 infants were born to opioid-addicted mothers last year. Just over half of them will live the toughest days of their lives in their first week outside the womb.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

Individual Opioid Injury Claim Types

A MASS TORT NEXUS OVERVIEW:

by John Ray

A great deal of media attention has focused on lawsuits filed by States, Counties and Cities against the manufacturers of opioids, yet less attention has been given to viable individual opioid patient claims against these same companies. This article is the second in a series published by Mass Tort Nexus to have you gain a better understanding of the vast number of opioid claims, which may be filed on behalf of individual victims of the opioid crisis. Please also read the first article in the series (link to the first article).

This article is intended to cover the major categories or types of potential opioid individual claims based on injury or adverse event type.

Overdose resulting in death

Overdose without death

Opioid Addiction

Neonatal Abstinence Syndrome

Birth Defects

Heart attack

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit to learn more about what your firm can do to help individual victims of the opioid epidemic.

In addition to providing information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs, you will also receive information related to marketing to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

Opioid Litigation Individual Claims

Given the publicity surrounding the opioid crisis gripping our nation, most of the country is aware that opioid addiction and overdose risk is far greater than the opioid litigation defendants, their Key Opinion Leaders and Front Groups led us to believe.

The researchers at Mass Tort Nexus estimate that there are approximately 250,000 individuals and families with viable claims against the opioid litigation defendants; however, yet few firms have engaged in an effort to retain these clients and provide the legal representation they desperately need and deserve. This fact is somewhat astounding given that many of these potential plaintiffs have been represented by your personal injury firm in the past.

Overdose Resulting in Death

When an individual, often a juvenile, dies from an opioid overdose, family members are left behind to suffer the pain and costs.

Significant evidence exists to demonstrate that the opioid manufacturers negligently and wantonly deceived doctors and the public about the risks associated with opioids. They continued to do so, even after it was apparent that their deceptions were resulting in loss of life and other severe injuries caused by their products.

The potential number of wrongful death claims which could be brought against the opioid defendants, could exceed the total number of wrongful death claims brought for any other reason over the next decade.

Overdose Deaths Soared as Big Pharma Reaped the Profits

According to the National Institute for Drug Abuse revised report from March 2018, despite the efforts to stem the opioid crisis, 115 people in the United States die from an Opioid overdose every day.

Overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.

More Americans died from drug overdoses in 2016 than the number of American lives lost in the entirety of the Vietnam War, which totaled 58,200.

Prescription opioid deaths account for the majority of the increase in overdose deaths since 1999. It is no coincidence that the astounding increase in drug over dose statics beginning in 1999 coincides with the opioid manufactures campaign (beginning in the late 1990s) to convince doctors, based on false information, that past concerns related to opioids were unwarranted.

The opioid manufacturers are accused of using big tobacco style techniques to increase the consumption (and their profits) from increased sales of opioids. The manufacturers are accused of taking a page from the big tobacco play book, using front groups and key opinion leaders in the health field to promote the narrative that the risk associated with opioids was not significant. The false narrative promoted by the opioid manufacturers has been unveiled at the cost of an enormous loss of human life and suffering.

The link between the success of the opioid manufacturers deceptions, and the devasting effects caused by their fraudulent acts can be seen in a single chart. As the opioid manufacturers made billions of dollars, individual patients relying on these companies paid the price.

Overdose Without Death

Opioid overdose deaths are devasting to the family of the victim. Opioid overdoses that do not result in death can be equally or even more devasting.

Victims of opioid overdoses often suffer brain damage, heart damage and other adverse events that will impact their lives and their families permanently.

In many cases, the financial and other damages caused by an overdose not resulting in death will exceed those of overdose cases resulting in death.

Opioid Addiction

Despite the opioid litigation defendants attempts to blame the victims and their doctors, the blame for the meteoric rise in opioid addiction coincided with the opioid manufacturers fraudulent practices designed to deceive doctors and the public about the risk of opioid use.

According to the CDC, by 2016 2.1 million Americans suffered from opioid addiction (opioid use disorder) and 2.1 million more Americans received their first opioid prescription in the same year, guaranteeing the continuation of the Country’s opioid addiction epidemic.

Not every opioid addict will have a viable claim for damages against the opioid manufacturers.

Neonatal Abstinence Syndrome

By 2012, the National Institute for Health had recognized a dramatic increase in Neonatal Abstinence Syndrome (NAS) and the number of babies born with NAS has continued to increase since that time.

NAS occurs when a mother ingests opioids during pregnancy. Despite the risks associated with NAS and opioids, the opioid manufacturers are accused of aggressively promoting the use of opioids for pain commonly associated with pregnancy.

In addition to damage to the fetus before birth, opioid consumption during pregnancy often results in the infant being born addicted to opioids. The long term impact of NAS, often results in consequences that will plague the infant for the remainder of their lives.

Impaired cognitive abilities, severe behavioral issues, as well as an increased susceptibility to opioid use and addiction later in life are among a long list of complications associated with NAS.

Babies born with NAS and opioid related birth defects will often suffer from the day they are born until the day they die. The opioid defendant’s actions leading to the harm of infants should be a great source of shame for the opioid defendants; however, at this point, it appears that the opioid defendants have no shame. They continue to blame others for what is clearly their fault.

Birth Defects

There is significant support in the medical literature demonstrating opioids cause numerous severe birth defects.

One of the types of birth defects potentially caused by maternal opioid use is Tetralogy of Fallot.

Tetraolgy of Fallot is a heart defect that presents with some or all of the following defects in the infants heart: Overriding Aorta, Pulmonary Stenosis, Ventricular Septal Defect and Right Ventrial Hypertrophy.

Any of the defects associated with Tetraolgy of Fallot can result in infant death or the need for multiple cardiac surgeries and a permeant decrease in quality of life.

Neural Tube Defects may also be caused by maternal opioid use. Neural Tube Defects include Spina Bifida, Anencephaly and Encephalocele. Any of these birth defects can result in infant death, the need for multiple corrective surgeries over numerous years, as well as a permanent decrease in quality of life.

The above is only a partial list of birth defects which are associated with maternal opioid use. Given the increase in clinical interest and study surrounding opioid use, we expect to see additions to the medical literature demonstrating a large number of opioid associated birth defects, in the near future.

HEART ATTACK

There is overwhelming support in the medical literature demonstrating an increased incident of heart attack and other coronary issues associated with opioid use.

Cardiac damage and heart attack are common secondary issues related to opioid overdose; however, these adverse events appear to occur at a high rate in all opioid users without regard to the occurrence of an overdose. The increased risk appears to exist for patients that are predisposed to cardiac problems, as well as those who are not.

The conditions and adverse events associated with opioid use covered in this article do not include all the medical issues associated with opioid use.

Attend the July Mass Tort Nexus Opioid summit for a more through understanding of the medical conditions which may give rise to viable individual claims against the opioid defendants.

Opioid litigation in New York and other state courts, where hundreds of counties and cities have filed lawsuits against opioid manufacturers and distributors, are now moving forward even with the explosion in the Federal Opiate Litigation MDL 2804 OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where more than 500 states, counties, cities as well as unions, hospitals and individuals have filed lawsuits against the opioid industry as a whole.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

In a two-page order issued in March by Judge Jerry Garguilo of the Suffolk County Supreme Court, New York where he ruled that there is “no compelling reason to impose a stay of proceedings” until the FDA completes its own review of the benefits and risks of opioids. The lawsuits by most of the counties in New York, which have been consolidated in Garguilo’s court, are “backward-looking” toward allegedly fraudulent marketing materials and tactics the drug companies used to convince doctors and patients their products had low risk of addiction.

Oklahoma, one of at least 20 states besides New York that have opioid lawsuit dockets against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

The New York state court lawsuits are joined by another somewhat unique group of plaintiffs in the legal battle over the opioid-epidemic with class actions filed by consumers who claim they’re seeing skyrocketing health insurance costs as a result of the crisis.

The suits, filed in New York and four other states, were brought by individual persons against opioid manufacturers and distributors, and are among the few class actions filed against drug makers and marketers. The vast majority of cases have been separate actions brought by government entities like cities and counties.

The proposed classes include businesses and individuals who paid for health insurance as part of employer-sponsored plans.

“We don’t know anyone who in the litigation is addressing the private sector harms to consumers and businesses from increased premiums and other insurance costs that flow to anyone in the health insurance market as a result of the fact that insurers are paying more for addictions,” said Travis Lenkner, one of the plaintiffs attorneys filing the cases.

The opioid cases add a new type of plaintiff into the wide-reaching opioid litigation, which have also includes states, Native American tribes, pension funds and hospitals.

John Parker, senior vice president of the Healthcare Distribution Alliance, speaking on behalf of distributors AmerisourceBergen Drug Corp., Cardinal Health Inc. and McKesson Corp., all named as defendants, called the opioid epidemic a “complex public health challenge.”

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated,” he said in a statement. “Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”

Purdue Pharma spokesman Bob Josephson noted that his company’s products account for less than 2 percent of all opioid prescriptions. Johnson & Johnson’s Janssen Pharmaceuticals defended the labels on its prescription opioids and called the allegations “baseless and unsubstantiated.”

Representatives of the other manufacturing defendants, which include Endo Health Solutions, Teva Pharmaceutical Industries and Insys Therapeutics Inc., did not respond to requests for comment.

It is now fairly common knowledge in the legal world that there is more than enough data that links increased health insurance costs to the opioid epidemic as well as the overall catastrophic impact of the flood of opioids into the America marketplace.

The suits cite statistics. In California, for instance, health insurance premiums for family coverage increased 233.5 percent from 2002 to 2016. Monthly premiums for the plaintiff in that case, Jordan Chu, jumped from $160.52 in 2016 to $240.76 this year. New Jersey residents with private health insurance spent $5,081 in insurance premiums in 2014, up from $2,454 in 2001. And an average family plan in New York with annual costs of $9,439 in 2003 had jumped to $19,375 in 2016.

Plaintiff counsel stated that they will be filing suits in more states and fight any attempts to transfer these cases to the Northern District of Ohio, where U.S. District Judge Dan Polster is overseeing the opioid multidistrict litigation, MDL 2804, even though the cases were filed in federal courts. A damaging discovery win for the plaintiffs was the order of May 18, 2018, see DEA ARCOS Database Access Order May 8, 2018 MDL 2804, where Judge Polster ordered the DEA to turn over distribution data for all 50 states based on the revelations in a prior DEA related order where the Opioid Drug distribution data provided very solid information on all the parties involved in creating the opioid crisis over the last 15 years.

The New York court docket parallels the federal and many other opioid based complaints, filed in state courts across the country where parties have decided to pursue their claims in their state courts versus the federal docket. These filings in both state and federal courts, will only increases the pressure on manufacturers and wholesalers to either win dismissal of these cases or prepare for an accelerated trial schedule.

There are currently more than 500 of the nation’s 3,200 counties have sued and plaintiff lawyers hope to soon get that number to 1,500, which some lawyers consider critical mass for a settlement.

The defendant companies argue they can’t be held liable for selling a legal product sold only with a doctor’s prescription whose distribution was controlled and overseen, from manufacturing to retail sales, by federal and state regulators.

The plaintiffs argue manufacturers used a variety of tactics, including misleading marketing materials and highly paid physician-influencers, to convince prescribing physicians their products were safe for treating chronic pain when, in fact, they were highly addictive.

In the March order, Judge Garguilo rejected the defendants’ claim that the FDA has exclusive authority to determine whether, in effect, opioids should be sold for anything other than relieving the pain of terminal illness. Regardless of what the FDA determines, the judge said, the municipal plaintiffs have the right to seek redress for their costs associated with addiction.

“Because the focus of this lawsuit is on the state of scientific knowledge that existed when the defendants made their marketing claims, there is no risk of inconsistent rulings, and none of the current studies will have any bearing on whether the defendants’ representations were misleading when made,” the judge wrote. The court isn’t being asked to decide the risks and benefits of opioids but whether the defendants misrepresented those risks and benefits, he added.

In case the defendants didn’t grasp the judge’s ultimate goal, the judge restated his “previously expressed desire” for a “prompt resolution of this matter.” The federal judge overseeing multidistrict litigation in Ohio, Judge Dan Aaron Polster, has similarly urged defendants to engage in settlement talks, although a global resolution of the litigation could prove difficult to negotiate.

In addition to hundreds of cases consolidated in federal court, the defendants face a wave of litigation in state court, like the New York cases, as well as lawsuits and investigations by state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts. The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

For those looking to tap into the opioid litigation or learn what the current status is in both state and federal court opioid litigation, please visit www.opioidcrisissummit.com where Mass Tort Nexus is hosting national political leaders and lead opiate counsel who are active in the day to day opioid crisis and have the most up to date case information during the two day event taking place July 21-22, 2018 in Fort Lauderdale.

To summarize the view in Oklahoma and other states who are pursuing the Opioid prescription drugmakers in courts all across the country, Oklahoma Attorney General Mike Hunter stated in his filings “Defendants created the worst public health crisis in modern history. Families destroyed,”adding “Children killed. Babies addicted. Morgues overflowing. Prisons full.” This is a common view across the entire United States at this point.

Oklahoma, one of at least 13 states that have filed lawsuits against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

“We appreciate the urgency Judge (Thad) Balkman saw in getting the case to trial,” Attorney General Mike Hunter said. “Oklahomans who have suffered immeasurably from the years of fraudulent marketing campaigns will see this case resolved sooner rather than later.” Hunter said Balkman scheduled the trial to begin May 28, 2019.

Within the last 2 weeks, state attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee lawsuits have now joined many other states who have filed lawsuits asserting that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

The companies deny wrongdoing and say they complied with Federal Drug Administration requirements that include warning labels showing potential risks that come with using their drugs. “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution,” Purdue Pharma said in a statement Friday. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain. Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

The state lawsuits are separate from pending lawsuits in Ohio by dozens of local governments, and lawsuits by Native American tribes in the Dakotas and Oklahoma.

In South Dakota, the Rosebud Sioux Tribe, Flandreau Santee Sioux Tribe and the Sisseton Wahpeton Oyate filed a federal lawsuit in January against 24 opioid industry groups. See https://www.indianz.com/News/2018/04/11/navajonationopioid.pdf. n Oklahoma, a federal judge has ruled that another similar lawsuit by the Cherokee Nation cannot be tried in tribal court, and Cherokee Nation Attorney General Todd Hembree told the Tulsa World that the tribe will re-file the lawsuit in state court.

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country. At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

Will litigation in most every state in the union paired with the National Opiate Prescription MDL 2804 reign in the Opioid industry that’s earned billions and billions of dollars over the last 20 years, all at the expense of the people of the United States and their families? If history is a gauge of how things will end up, chances are a big “NO” as money and greed at the corporate levels have traditionally overruled anything affiliated with long term public health concerns in our for-profit healthcare system currently entrenched in the United States.

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small. Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country. At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

Opiate Use Has Increased While Realtime Data Shows There’s A Diminishing Return

By Mark A. York (May 11, 2018)

Why was there a 30% rise in opioid overdoses in 2017

(MASS TORT NEXUS MEDIA)From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone.

See the data on the 30% rise in opioid overdoses between 2016 and 2017, click CDClink here.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.

The increased emergency room visits also include more young children aged three to fourteen years old, which truly reflects on the unknown number still available opiates that are readily accessible to anyone who has an interest in getting them, and often with an inadvertent and tragic risk to younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

“A small West Virginia town of 3,000 people got 21 million pills”

Drug companies deluged tiny towns in West Virginia with a monsoon of addictive and deadly opioid pills over the last decade, according to ongoing investigations by various public and private entities. After Opioid Big Pharma has reaped billions in profits over the last 15 years at the expense of US citizens, often those in the most rural and distressed areas of the country, it now appears that the time has come for Big Pharma to be called to answer for its conduct.

For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data. These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucky where for some reason the opioid industry chose to focus on, the how and why will be address in the federal and state courts across the country, as the opioid crisis has caused the “Opiate Prescription Multidistrict Litigation MDL 2804”, to be created and heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

WHERE WAS THE OFFICIAL OVERSIGHT?

The House committee repeatedly asked if the company thought these orders were appropriate and what limits—if any—it would set on such small towns. Miami-Luken would not respond to a request for comment. The committee had similar questions for HD Smith, who delivered 1.3 million hydrocodone and oxycodone pills to a pharmacy in Kermit—the 406-person town—in 2008.

“If these figures are accurate, HD Smith supplied this pharmacy with nearly five times the amount a rural pharmacy would be expected to receive,” the committee wrote. It noted that the owner of that Kermit pharmacy later spent time in federal prison for violations of the Controlled Substance Act. Still, the committee pressed the question of whether HD Smith thought its distribution practices were appropriate.

“We will continue to investigate these distributors’ shipments of large quantities of powerful opioids across West Virginia, including what seems to be a shocking lack of oversight over their distribution, all the while collecting record breaking profits and paying sale reps in the field enormous bonuses. This is the pattern that all Opioid Big Pharma has followed across the United states for the last 20 years, pay field sales rep many thousands of dollars on bonuses, to push opiates on doctors, hospitals and anyone else who can move drugs into the healthcare treatment assembly line.

OPIOIDS FOR CASUAL PAIN MANAGEMENT PUSHED BY BIG PHARMA

Why did the emphasis on pain management in the 1990s result in a focus on opioid prescriptions? One reason may have been aggressive marketing efforts by opioid drug makers. For example, from 1996 to 2001, Purdue Pharma held more than 40 pain management conferences for healthcare providers to promote the use of its new OxyContin® extended-release formula of oxycodone. Sales surged from $45 million in 1996 to $1.1 billion a year in 2000—an increase of well over 2000%.

“We were told way back in the ’90s that these drugs were safe, that they wouldn’t hurt people, and that it was imperative to control pain,” Dr. Kalliainen recalls. Then, in 2007, Purdue admitted it had misled doctors into thinking OxyContin was less easily abused than other drugs in its class. It agreed to pay $600 million in fines and other fees to the Justice Department. Something else has changed in the culture as well, says Dr. Kalliainen. Patients seem to be in as much emotional pain as physical pain. “I’ve been in practice for 16 years now, and there’s been a huge increase in free-floating anxiety in patients,” she says.

US physicians often that find writing a prescription for an opioid is the most convenient way to respond to their patients’ demands, Dr. Kallianen says. As a resident in the 1990s, she remembers being told by the attending physician to write prescriptions for 60 or 70 opioid tablets for nearly every surgery patient. “You started a whole generation of physicians who are out there saying, ‘Write them for 60 [tablets] so they don’t call in.’”

One reason the practice has persisted is that surgeons often don’t know what effect their prescriptions are having, says Dr. Kalliainen. “We don’t see somebody dying of an overdose or becoming addicted. We don’t know if somebody is coming in and stealing their medications from their medicine cabinet and then having a problem. All the negative effects are away from our direct vision. So we’re not taking as much responsibility.” But research shows that once they have received opioid drugs, many patients can’t stop using them. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later, despite weak evidence that the drugs are effective for chronic pain management.

Among people already abusing drugs, some studies suggest that the opioids serve as a bridge between other substances and heroin.] Even when patients don’t abuse the opioids themselves, the drugs prescribed to them may end up in the hands of people who do. Surveys of people who abuse opioids show that as many as 23.8% obtained the drugs from clinicians, and 53% obtained them from friends or relatives, most of whom obtained them from clinicians.

“It’s not like these are stolen off the truck,” says Brent J. Morris, MD, a shoulder and elbow surgeon at the Shoulder Center of Kentucky in Lexington, who has published extensively on opioid prescribing patterns. “Certainly, physicians play a role in this.”

RECENT FDA COMMENTS ON OPIOIDS

Opana ER: June 2017 U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.

Codeine and Tramadol Can Cause Breathing Problems for Children

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women issued on April 20, 2017.

These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active forms faster than other people. That can cause the level of opioids in these people to rise too high and too quickly.

January 2018 FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

FIGHTING THE OPIOiD FIGHT

In the United States, has been fighting a losing opioid battle for a long time now. With one study reporting that Americans consume approximately 80% of the world’s opioid drug supply. Given that painkillers make up the one of the largest classes of drugs manufactured around the globe, second only to cancer drugs, this is a rather staggering statistic: According to the CDC, more than a quarter of a billion prescriptions for opioid painkillers were written in 2013, the latest year for which data is available, and that number has almost certainly risen in recent years.

As these two latest studies show, not only are we losing the battle against opioid use – and, more importantly, abuse – but the battle itself is largely one that we should never have had to wage in the first place. A large portion of people who become addicted to opioids do so after receiving a prescription for long-term pain management. But as the JAMA study shows, it appears opioids are actually worse at managing chronic pain than non-opioid medications.

The primary reason for addiction and the correlating social problems is the casual acceptance by so many that opioids prescribed by a doctor are well intended and okay to use, not realizing that over time people tend to build up a tolerance for them. This means that patients have to take larger and larger doses in order to receive the same benefit as they did previously with smaller doses. This has been long known by doctors and researchers, including the Big Pharma Opioid marketing and sales teams, which was reinforced in the JAMA study. Participants reported that opioids were more effective than non-opioids early in the study, but at around six months they started to report that opioids the same or even less effective at managing pain than their non-opioid counterparts.

Other side effects include nausea and vomiting, mental health problems (including everything from confusion to depression), and full-blown chemical dependence. Then, there are the problems associated with opioid withdrawal. The upshot of all these side effects is that, even when opioids are working, they well may wind up causing the patient harm in other ways.

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

IS THERE A SOLUTION FOR THE OPIOID CRISIS?

People in many different professional areas are looking for ways to address the addiction problem that has arisen while simultaneously working to prevent future addictions. The concern is having the crisis split along political lines where conservative push for draconian solutions and liberals push for free treatment for everyone. Both solution are untenable and misdirected, but there are proponents for both strategies forming in camps across the country. .

Given the reduced effectiveness of opioid painkillers over time, doctors must look at finding newer and better ways to treat long-term and chronic pain, with a more fully evolved treatment protocol. This includes research and developing into safer medications, more active lifestyle review and changes by patients and a wider acceptance by the medical community of complementary therapies, such as meditation, yoga, tai chi, and massage – including the use of medical marijhuana. Awareness about these alternative pain relief methods need to be be included as part of any sincere program that provides solutions to the opioid crisis.

THE PRESCRIPTION OPIATES BEING PRESCRIBED

oxycodone (OxyContin, Percodan, Percocet)

hydrocodone (Vicodin, Lortab, Lorcet)

diphenoxylate (Lomotil)

morphine (Kadian, Avinza, MS Contin)

codeine

fentanyl (Duragesic)

propoxyphene (Darvon)

hydromorphone (Dilaudid)

meperidine (Demerol)

methadone

For another thing, public policy on illegal drugs needs to be significantly reconsidered, especially for less-addictive drugs like marijuana. A study published last year in the American Journal of Public Health showed that legalizing marijuana for recreational use can significantly reduce the number of opioid deaths. Considering there have been no known reports of a marijuana overdose ever according to the U.S. Drug Enforcement Administration (DEA), that seems like a pretty good tradeoff from a simple public health policy perspective.

Another way to fight the problem is to increase the availability of opioid agonist drugs, such as naloxone, not only to health care providers and emergency department staff but to trained first responders and others as well. Naloxone reverses the effects of both prescription opioids and illegal drugs, such as heroin, and it can be an important first step toward helping those with substance use disorders become well.

Finally, IN the emerging MDL 2804 (Opiate Prescription Litigation) the opioid drugmakers, distributors and pharmacies are being held accountable for marketing tactics and self-funded studies that may have overblown the effectiveness of their drugs. Many state, county, and local governments are bringing lawsuits, including RICO claims, against pharmaceutical companies in an attempt to offset costs for public health services that have been used to treat addictions and other medical conditions caused by opioid abuse. The DEA and the Department of Justice recently agreed to provide its data on prescription opioid sales to states and municipalities that are pursuing lawsuits.

The comparison is made to the Tobacco Litigation of the 1990’s which settled in 1998 for $200 billion, WITH he Opiate MDL 2804 litigation being expected to easily surpass that figure with conservative estimates reaching between $750 and $900 billion dollars.

“BY REMOVING FDA OVERSIGHT BIG PHARMA RUNS AMOK”

(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses. The FDA will receive comments on this proposal through February 5, 2018.

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States. The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

US ATTORNEY CREATES NATIONAL TASK FORCE TO CRACK DOWN ON OPIOID INDUSTRY

Attorney General Jeff Sessions today announced the creation of a new effort, the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force, to fight the prescription opioid crisis. The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors.

“Over the past year, the Department has vigorously fought the prescription opioid crisis, and we are determined to continue making progress. Today, we are opening a new front in the war on the opioid crisis by bringing all of our anti-opioid efforts under one banner,” said Attorney General Sessions. “We have no time to waste. Every day, 180 Americans die from drug overdoses. This epidemic actually lowered American life expectancy in 2015 and 2016 for the first time in decades, with drug overdose now the leading cause of death for Americans under age 50. These are not acceptable trends and this new task force will make us more effective in reversing them and saving Americans from the scourge of opioid addiction.”

The PIL Task Force will include senior officials from the offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for U.S. Attorneys, the Civil Division, the Criminal Division, and the Drug Enforcement Administration. The Task Force will coordinate the Department’s many efforts and tools to combat the opioid epidemic.

The PIL Task Force will combat the opioid crisis at every level of the distribution system. At the manufacturer level, the PIL Task Force will use all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices. The PIL Task Force will build on and strengthen existing Department of Justice initiatives to ensure that opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.

The Attorney General has also directed the PIL Task Force to examine existing state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide in those lawsuits. The federal government has borne substantial costs from the opioid crisis, and it must be compensated by any party whose illegal activity contributed to those costs.

The Department will also use all criminal and civil tools at its disposal to hold distributors such as pharmacies, pain management clinics, drug testing facilities, and individual physicians accountable for unlawful actions.

The PIL Task Force will use criminal and civil actions to ensure that distributors and pharmacies are obeying Drug Enforcement Administration rules designed to prevent diversion and improper prescribing. It will use the False Claims Act and other tools to crack down on pain-management clinics, drug testing facilities, and physicians that make opioid prescriptions.

The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law. The PIL Task Force will build upon and expand the efforts of the existing Opioid Fraud and Abuse Detection Unit. Created in August 2017, the Unit uses sophisticated data analysis to identify and prosecute individuals who are contributing to the opioid epidemic, including pill-mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.

The PIL Task Force will also work closely with the Department of Health and Human Services to investigate and hold accountable any parties who engage in illegal activity surrounding prescription opioids. The Attorney General has directed the PIL Task Force to establish immediately a working group to: (1) improve coordination and data sharing across the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.

This new Task Force will build on a number of new initiatives begun by Attorney General Sessions over the past year that will help us end the drug crisis, including the following:

In July, the Attorney General announced charges against more than 120 defendants, including doctors, for crimes related to prescribing or distributing opioids and other dangerous narcotics.

One week later, the Attorney General announced the seizure of AlphaBay, the largest criminal marketplace on the Internet. This site hosted some 220,000 drug listings – including more than 100 vendors advertising fentanyl – and was responsible for countless synthetic opioid overdoses, including the tragic death of a 13-year old in Utah.

In August, the Attorney General created the Opioid Fraud and Abuse Detection Unit, a new data analytics program to help find evidence of overprescribing and opioid-related health care fraud.

The Attorney General then assigned 12 experienced Assistant United States Attorneys to opioid “hot-spots” to focus solely on investigating and prosecuting opioid-related health care fraud. By November they had begun issuing indictments.

In October, the Department announced the first-ever indictments of Chinese nationals and their North American-based traffickers and distributers for separate conspiracies to distribute fentanyl and other opioids in the United States.

Also in October, the DEA announced the establishment of six new enforcement teams focused on combatting the flow of heroin and illicit fentanyl into the U.S. These enforcement teams are based in communities facing some of the most significant challenges with heroin and fentanyl.

In 2017, the DEA held two of its National Prescription Drug Takeback Days, when people can dispose of unnecessary and potentially dangerous drugs with no questions asked. In total, DEA took a record 956 tons of drugs out of American communities.

In January 2018, the Department announced a new resource to target traffickers who sell drugs online called J-CODE: Joint Criminal Opioid Darknet Enforcement team. The J-CODE team will coordinate efforts across the FBI’s offices all around the world – bringing together DEA, our Safe Streets Task Forces, drug trafficking task forces, Health Care Fraud Special Agents, and other assets – effectively doubling the FBI’s investment into fighting against online drug trafficking.

Also in January 2018, the DEA announced a 45-day surge of Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs.

On February 7, 2018, the DEA placed all fentanyl analogues not already regulated by the Controlled Substances Act into Schedule I – the category for substances with no currently accepted medical use – for at least two years. This makes it harder for people to acquire illicit fentanyl and easier for law enforcement to investigate and prosecute drug traffickers.

The Department anticipates filing a statement of interest in the coming days in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors.